Reagan-Udall Expanded Access Navigator Ready To Launch
Web tool to help patients find expanded access program should go live in early June, focusing initially on oncology. That timing should help deflect efforts to enact “Right to Try” legislation.
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Expanded Access: Reducing The Contract Delay
While the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain access.
US FDA Expanded Access Pilot Launching Soon With Staffing Questions Unanswered
New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.
Gottlieb's "Right To Try" Sentiment: Law Fails To Address Difficulties Faced By Drugmakers
US FDA Commissioner suggests Congress may need to explore incentives for drugmakers to make investigational products available in the pre-approval phase.